MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, CONTINUOUS FLUSH

Model Number 45032

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Renal Failure (2041)

Event Date 02/21/2019

Event Type  Injury  

Event Description

It was reported that renal failure occurred.An angiojet solent proxi catheter was selected for use for an angiojet procedure in the left subclavian.The patient's lab values were within normal range pre-procedure, with the patient's creatine level at 1 mg/dl.The solent proxi catheter was ran for about 300 seconds, including 46 cc's in power pulse mode.Minimal contrast was used and saline was given during the procedure.A balloon was also used during procedure.After the procedure, the patient was noted to have acute renal failure, and the their creatine level on (b)(6) 2019 was 7 mg/dl.The patient was admitted to the unit for further observation due to the renal failure.No further complications were reported.

• Brand Name: ANGIOJET SOLENT PROXI
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8435900
• MDR Text Key: 139307815
• Report Number: 2134265-2019-02696
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR